The present invention relates to the art of internal organ transplant and, in particular, to techniques for removal of such organs from the body.
Recent success in transplantation of internal human organs such as the liver, pancreas, heart, kidney, etc. has lead to efforts directed toward maximum utilization of donors. Increasing the population of donors as well as multiple organ retrieval from a single donor have both been contemplated as ways to increase available organs. For example, it has been reported that in one country, the Netherlands, the annual occurrence of end-stage renal disease is 50/million population, while the donor population is only 26/million. Ruers, et al. "Non-Heart-Beating Donors: A Successful Contribution to Organ Procurement," Organ Procurement II Proceedings of the Second International Congress on Organ Procurement Oct. 3-5, 1985, Detroit, Mich., ppg. 28-30 (1986). In order to overcome this problem, Ruers, et al. have suggested that non-heart-beating donors who experience sudden circulatory arrest in an uncontrolled situation be accepted as donor candidates for kidney transplants.
Additionally, multiple organ procurement from a single donor would help alleviate the shortage of internal organs available for transplantation. Thus, in a procedure where a human heart or liver is removed, the kidneys (and/or the liver when the heart is first removed) can also be used to increase the number of available organs.
Problems incurred during organ transplantation relating to irreversible damage due to lack of blood supply in an organ or tissue, i.e., ischemia, are particularly troublesome in those procedures where a delay is experienced between cessation of spontaneous circulation and organ removal (whether occasioned because of uncontrolled conditions or multiple organ procurement procedures). Accordingly, traditional removal techniques, which include ex vivo flushing with a cold solution while the organ is immersed in, for example, a vessel filled with an ice-slush, have been enhanced by in situ preservation of the organ(s). Preservation techniques must be initiated in the uncontrolled situation immediately upon cessation of cardiac activity and continued until removal. Similarly in multiple organ procurement, in situ preservation must be maintained from cessation of spontaneous circulation until removal.
A technique known in the art is to simultaneously flush and cool the organ(s) in situ, whereby the oxygen demand of the organ can be reduced while cleansing the organ. One device known in the art for in situ flush cooling is a double balloon triple lumen catheter, which can be inserted into the common iliac artery and aorta. A lower balloon is inflated and the catheter pulled back until the lower balloon is seated at the aortic bifurcation, at which point the upper balloon is inflated. When both balloons are inflated, hopefully that part of the aorta is isolated where the circulatory conduits leading to the visceral organs, especially the renal arteries, are located. In view of the fixed nature of the occlusive balloons in the double balloon triple lumen catheter, there exists the possibility of failing to correctly isolate the appropriate segment of the aorta. Furthermore, the fixed nature of the balloons may require different sizes. Finally, the fixed double balloon configuration minimizes the flexibility to isolate selected segments of the aortic passage for introduction of flush solution.
In addition to the drawbacks set forth above with regard to the use of the double balloon triple lumen catheter, observed in non-heart-beating donors, other deficiencies have recently been observed in in situ flush cooling which suggest that kidneys, for example, are poorly flushed and cooled. Consequently, it has been deemed appropriate to identify as a standard those flush cooling requirements, such as volumetric flow and pressure as they relate to cooling, and the technique(s) necessary to effect proper organ procurement for purposes of regaining viability after transplantation.
Thus, it is an object of the present invention to provide a device and method for isolating the internal visceral organs for multiple organ procurement.
Another object of the present invention is to provide a device in which adequate flush and cooling of visceral organs can be effected in situ in order to preserve multiple visceral organ(s) for transplantation.
Other objects will be made known to the skilled artisan in view of the following disclosure.